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GUIDANCE DOCUMENT

Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II) Guidance for Industry February 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-3324
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II), collectively referred to as HTLV-I/II, by blood and blood components.  These recommendations apply to the collection of Whole blood and blood components, except Source Plasma.

 

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All written comments should be identified with this document's docket number: FDA-2018-D-3324.

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